Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma
- Registration Number
- NCT03568929
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- Individuals who were or are being treated for refractory Follicular Lymphoma (FL) according to the product information for idelalisib and treatment guidelines in routine clinical practice.
- Individuals included in clinical trials on idelalisib within the timeframe of this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Idelalisib Idelalisib Participants who have been or are currently being treated with 100 or 150 mg of idelalisib
- Primary Outcome Measures
Name Time Method Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AE), Serious AEs, Special Situation Reports, Adverse Drug Reactions (ADR), and Serious ADRs 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period) DOR is defined as the interval from the first documentation of a clinical response with or without radiological confirmation to the earlier of the first documentation of disease progression or death from any cause.
Time to Next Treatment (TTNT) 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period) TTNT is defined as the interval from the initiation of treatment with idelalisib to the earlier date of the initiation of next systemic treatment of Follicular Lymphoma (excluding palliative care or palliative radiation) or death from any cause.
Overall Survival (OS) 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period) OS is defined as the interval from the date of initiation of idelalisib to death from any cause.
Overall Response Rate (ORR) 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period) ORR is defined as the proportion of participants who achieve a clinical response with or without radiological confirmation as documented within their electronic health record after the initiation of treatment with idelalisib and during the treatment period with idelalisib.
Progression-free Survival (PFS) 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period) PFS is defined as the interval from the date of initiation of idelalisib to the earlier date of the first documentation of disease progression or death from any cause.
Trial Locations
- Locations (88)
University General Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
University General Hospital of Patras
🇬🇷Patra, Greece
Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital
🇧🇪Antwerpen, Belgium
Athens Medical Center-Psychikon branch
🇬🇷Athens, Greece
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
AHEPA University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Instituto Português de Oncologia Francisco Gentil, Centro Regional de Lisboa SA
🇵🇹Lisbon, Portugal
Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord
🇫🇷Amiens Cedex 1, France
Centre Hospitalier Bourg-en-Bresse Fleyriat
🇫🇷Bourg-en-Bresse, France
Hôpital Privé Sévigné
🇫🇷Cesson-Sevigne, France
Centre Hospitalier de Cannes
🇫🇷Cannes, France
Centre Hospitalier Chalon sur Saône William Morey
🇫🇷Chalon-Sur-Saone, France
Centre Hospitalier Universitaire Estaing
🇫🇷Clermont-Ferrand, France
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
🇫🇷Grenoble, France
CHU de Dijon
🇫🇷Dijon, France
Clinique Victor Hugo
🇫🇷Le Mans Cedex 2, France
Centre Hospitalier de Lens
🇫🇷Lens, France
Hôpital de la Conception
🇫🇷Marseille, France
Centre Hospitalier Le Mans
🇫🇷Le Mans, France
Centre Hospitalier Régional d'Orléans
🇫🇷Orléans, France
Centre hospitalier de Perigueux
🇫🇷Pessac, France
Klinikum Frankfurt Hochst
🇩🇪Frankfurt, Germany
Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite Cedex, France
Hopital Bretonneau, Centre Henri Kaplan
🇫🇷Tours, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers Cedex, France
Klinikum Südstadt Rostock
🇩🇪Rostock, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede
🇩🇪Westerstede, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Henry Dunant Hospital
🇬🇷Athens, Greece
Saint James's Hospital
🇮🇪Dublin, Ireland
Midland Regional Hospital - Mullingar
🇮🇪Mullingar, Ireland
Ospedali Riuniti di Ancona, Clinica Ematologica
🇮🇹Ancona, Italy
Ospedale Mazzoni
🇮🇹Ascoli Piceno, Italy
Azienda Ospedaliera Policlinico di Bari
🇮🇹Bari, Italy
Monsignor Raffaele Dimiccoli Hospital
🇮🇹Barletta, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
🇮🇹Catania, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
Ospedale di Civitanova Marche
🇮🇹Civitanova Marche, Italy
Azienda Ospedaliero - Universitaria Careggi
🇮🇹Florence, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Presidio Ospedaliero di Livorno
🇮🇹Livorno, Italy
Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
Istituto Scientifico Universitario San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara
🇮🇹Novara, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Italy
Azienda Ospedaliera di Perugia
🇮🇹Perugia, Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Italy
Azienda Unita Sanitaria Locale di Ravenna
🇮🇹Ravenna, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
🇮🇹Rionero in Vulture, Italy
Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri
🇮🇹Roma, Italy
Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Universita degli Studi di Roma La Sapienza
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte
🇮🇹Siena, Italy
Ospedale San Bortolo di Vicenza
🇮🇹Vicenza, Italy
Fundació Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitari Mútua Terrassa
🇪🇸Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital De Cabuenes
🇪🇸Gijon, Spain
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Spain
Hospital Universitario Donostia
🇪🇸Gipuzkoa, Spain
Institut Català d'Oncologia
🇪🇸L'Hospitalet de LLobregat, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital Universitario Rey Juan Carlos
🇪🇸Móstoles, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Spain
Hospital Universitari Arnau De Vilanova (Huav)
🇪🇸Valencia, Spain
Hospital de Día Quirónsalud Zaragoza
🇪🇸Zaragoza, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
St George's Healthcare NHS Trust
🇬🇧London, United Kingdom
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Velindre NHS Trust
🇬🇧Cardiff, United Kingdom
South Tees Hospitals Nhs Foundation Trust
🇬🇧Middlesbrough, United Kingdom
Abertawe Bro Morgannwg University Health Board
🇬🇧Swansea, United Kingdom
Hospital San Pedro de Alcantara
🇪🇸Madrid, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain